1. Field of the Invention
This invention relates to uterine manipulators, and more particularly to a reinforcing insert for a manipulator for providing increased stiffness to the manipulator during manual manipulation of the manipulator.
2. Related Art
A uterine manipulator is commonly used in properly positioning the uterus so that, for example, inaccessible areas may be viewed through a laparoscope extending through a small incision in the abdominal wall. A manipulator which includes an injector is usable for injecting fluids into the uterine cavity. This procedure is followed, for instance, in determining fallopian tube patency by noting the flow of an injected fluid from the uterus into the fallopian tubes.
One form of uterine manipulator is disclosed in U.S. Pat. No. 4,775,362. This manipulator is available commercially under the name Kronner Manipujector from UNIMAR, Inc. of Wilton, Conn.
This manipulator has a manually flexible elongate plastic tube formed in an arc with a radius of 5.5 inches. A wall encloses an elongate interior forming a primary passage, and has an insertable end, with an outlet port, adapted to be inserted through the cervical canal into the uterine cavity. An opposite end has an inlet port which locates outside the external opening of the vagina with the manipulator in place. A secondary passage extends therealong in the wall and has a charge port adjacent to its opposite end. The passage terminates in a discharge port adjacent to the insertable end, and serves to channel fluid introduced thereinto along the tube to the discharge port.
A balloon is mounted on the insertable end of the tube with the interior of the balloon communicating with the discharge port. The balloon is adapted to be inflated with fluid, typically a gas, channeled by the secondary passage.
An elongate plastic sheath has an internal passage that is open along one side for freely receiving the tube. The tube is thereby freely slidable relative to the sheath. Once inserted at a desirable position in the uterus, the tube may fixed in axial position relative to the sheath.
This manipulator is effective for injecting fluids into the uterus through the primary passage, typically when the cervix is sealed by an inflated balloon. It is also useful for positioning the uterus through manipulation of the tube. However, due to the flexibility of the tube, the tube often bends, making manipulation difficult. Procedures in which additional manipulative control is useful includes laparoscopic assisted hysterectomies, treatment of patients with severe adhesions, and other long-lasting laparoscopic procedures. In these procedures, the tube has enough flexibility to make manipulation difficult.
A uterine injector is a tube that is soft and flexible for patient comfort, and has a small hole in an insertable end that is used to inject fluids into a uterus after the entrance to the uterus is sealed by the inflation of a balloon attached near the insertable end. This device, also available from UNIMAR, Inc., is similar to the manipulator described in U.S. Pat. No. 4,089,337 except for the softness of the tube. Since the tube is so flexible it is difficult to properly insert into the cervical canal. A thin wire with a plastic coating and an S-shaped coil on one end for a handle has been used to provide sufficient stiffness to the tube to allow it to be inserted more easily into the uterus. Once the tube is inserted the wire is removed, since the only function of the tube is as an injector. Due to the softness and lack of shape of the tube, even with the wire inserted, the tube is not usable to manipulate the uterus.